510(k) K241872

Remanufactured EndoWrist ProGrasp Forceps (420093) by Rebotix — Product Code QSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2024
Date Received
June 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Surgical, Computer Controlled Instrument, Remanufactured
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

As intended with the originally cleared instrument.